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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer

MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer (NCT04808323) is a Phase 1 interventional studying Rectal Adenocarcinoma, sponsored by Medical College of Wisconsin. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is a prospective, open-label, phase I design.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Rectal Adenocarcinoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 22 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 18. 2. Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum. 3. Determined on staging evaluation to be clinical stage I, II or III. 4. No concerning unequivocal or biopsy-proven metastatic disease. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise. 5. Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry. 6. History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment. 7. MR of the rectum is mandatory for staging and follow-up. 8. Chest CT scan within 45 days prior to study entry. 9. Radiation treatment planning abdominal CT. A mandatory pelvic MR will be done as a simulation (SIM) (ideally with interpretation). The CT SIM will not be done with interpretation. Ability to undergo abdominal MR scans for staging and radiation planning and follow-up is mandatory. 10. Laboratory values (CBC, Chem24) 45 days prior to treatment as follows: 1. Carcinoembryonic antigen (CEA) (any value). 2. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3. 3. platelet count at least 50,000 cells/mm3. 4. blood count (hemoglobin) at least 8.0 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 4 x upper limit of normal. 6. Total bilirubin \< 2 x upper normal mg/dL. 7. Alkaline phosphatase \< 4 x upper limit of normal. 11. Not on hemodialysis. 12. Ability to swallow oral medications. 13. Patients must be determined by medical oncology to be a candidate for systemic chemotherapy. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age ≥ 18. 2. Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum. 3. Determined on staging evaluation to be clinical stage I, II or III. 4. No concerning unequivocal or biopsy-proven metastatic disease. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise. 5. Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry. 6. History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment. 7. MR of the rectum is mandatory for staging and follow-up. 8. Chest CT scan within 45 days prior to study entry. 9. Radiation treatment planning abdominal CT. A mandatory pelvic MR will be done as a simulation (SIM) (ideally with interpretation). The CT SIM will not be done with interpretation. Ability to undergo abdominal MR scans for staging and radiation planning and follow-up is mandatory. 10. Laboratory values (CBC, Chem24) 45 days prior to treatment as follows: 1. Carcinoembryonic antigen (CEA) (any value). 2. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3. 3. Platelets ≥50,000 cells/mm3. 4. Hemoglobin ≥ 8.0 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 4 x upper limit of normal. 6. Total bilirubin \< 2 x upper normal mg/dL. 7. Alkaline phosphatase \< 4 x upper limit of normal. 11. Not on hemodialysis. 12. Ability to swallow oral medications. 13. Patients must be determined by medical oncology to be a candidate for systemic chemotherapy. 14. Patients must provide study-specific informed consent prior to study entry. 15. Negative serum pregnancy test (if applicable). 16. Women of childbearing potential and male participants who are sexually active must practice adequate contraception. Exclusion Criteria: 1. Biopsy-proven distant metastatic disease or high clinical concern for metastatic disease and tumor conference consensus of stage IV disease. 2. Prior invasive malignancy (except nonmelanomatous skin cancer, noninvasive breast cancer (DCIS), or prostate cancer under active surveillance). Other malignancies are allowed if patient has been disease free for a minimum of three years 3. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. 4. Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection or vascular access insertion. 5. Severe, active comorbidity, defined as follows: 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last six months. 2. Transmural myocardial infarction within three months prior to study entry. 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. 4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration. 5. Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function. 6. Any unresolved intestinal obstruction. 7. Acquired immune deficiency syndrome (AIDS), based upon current Centers for Disease Control and Prevention (CDC) definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because patients receiving antiretroviral therapy may experience possible pharmacokinetic interactions with required treatment medications, such as capecitabine. 8. Absence of any significant medical comorbidity which would preclude the consideration of major intestinal surgery. 6. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women three months after study therapy is completed and for men six months after study therapy is completed. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 7. Participation in another interventional clinical treatment trial while on study (observational trials are permitted). 8. Patients taking nonprotocol-specified chemotherapy agents or immune-modulating agents for other medical conditions are not permitted to participate in this trial. Any medication questions should be reviewed by the PI. 9. Poor functional status such that patients are not able to be positioned for radiation treatments. 10. Gadolium allergy. 11. If age over 60, history of hypertension, diabetes or liver transplant, and glomerular filtration rate (GFR) at enrollment is \< 30.

Treatments Being Tested

DRUG

Capecitabine

825 mg/m\^2 twice daily during radiation therapy. (Fluorouracil (5-FU) may be used at the discretion of the treating medical oncologists.) This chemotherapy will be given during the initial radiation dose (50 Gy over 25 frac) and continue for Cohorts A, B, and C.

DEVICE

Initial Dose of Radiation before Dose Escalation

50 Gy over 25 frac.

DEVICE

Cohort A: Dose Escalation Radiation

Cohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions.

DEVICE

Cohort B: Dose Escalation Radiation

Cohort B will receive 18 Gy boost for a total of 68 Gy over 34 total fractions.

DEVICE

Cohort C: Dose Escalation Radiation

Cohort C will receive 22 Gy boost for a total of 72 Gy over 36 total fractions.

DRUG

FOLFOX

After the completion of radiation, subjects will receive up to eight cycles of systemic chemotherapy. (FOLFIRINOX may be used at the discretion of the treating medical oncologists.)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04808323), the sponsor (Medical College of Wisconsin), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04808323 clinical trial studying?

This study is a prospective, open-label, phase I design. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04808323?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04808323?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04808323. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04808323. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.